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Regulations

FAQ

Clinical Trial Regulation Structure

Acts

  • Human Subjects Research Act

  • Pharmaceutical Affairs Act Enforcement Rules

  • Medical Care Act

Regulations

  • Regulations for Good Clinical Practice

  • Regulations on Human Trials

  • Good Manufacturing Practices for Western Pharmaceuticals

  • Regulations on Management of Medicament Samples and Gifts

  • Regulations on Serious Adverse Event Report

Directions

  • Investigational New Drug Application Guidance

  • Informed Consent Form Sample

  • Informed Consent Form Guideline

  • Pharmacogenetics Research Informed Consent Form Guideline

  • Investigational Medicinal Product Import and Export Application Checklist and Guideline

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